1 in 55,000 nurses report adverse drug reactions in 4 months

Liberal Democrat Spokesman for Health Paul Burstow MP, today branded the new electronic yellow card scheme for reporting Adverse Drug Reactions a 'farcical flop' after he revealed that in the first four months only 53 adverse drug reactions were reported using this scheme and only 6 of those were by nurses.

Ministers championed the new electronic system as a step into the 21st Century. However, despite National Audit Office warnings that only 10%-25% of adverse drug reactions go reported, just 1 nurse in 55,000 has reported an ADR in 4 months.

The news comes following figures from the Department of Health that show each week there are 410 reports and 12 people dying from adverse reactions to legal drugs.

Paul Burstow said:

"What rings loud and clear in this report is that health professionals are not doing enough or are not being told how to report adverse drug reactions. There is a gaping chasm, where rigorous reporting of adverse drug reactions should be.

"It is a scandal that Ministers have failed to heed the warnings that Adverse Drug Reactions are being hugely under reported. The promised move of the MCA into the 21st century has simply turned into a farcical flop The death toll from adverse drug reactions has leapt but Ministers have been disgracefully complacent.

"These figures must set alarm bells ringing in the Department of Health. Deaths from adverse reactions have been rising at a faster rate than doctors are prescribing medicines. These figures are only the tip of the iceberg. It is time that Ministers took further steps to ensure that the ways in which reactions to drugs are monitored and reported are effective and robust.

"People must feel confident that when they are ill and in need of medication, health professionals have asked the right questions to avoid potentially lethal chemical cocktails. Patients must also be reassured that drugs are being properly labelled and dosages properly recorded."

ENDS

Notes to editors

TOTAL NUMBER OF ADVERSE DRUG REACTIONS (ADRs) REPORTED TO THE CSM & MCA VIA THE ELECTRONIC YELLOW CARD SCHEME LAUNCHED 31ST OCTOBER 2002

Total

Number of reported ADRs by nurses 6

Total number of electronic ADRs 53

Taken from PQs 97138 & 88246

There are around 330,000 nurses who are eligible to report Adverse Drug Reactions. In paragraph 2.2 of the report published on the 16th January 2003 by the National Audit Office, Safety, quality, efficacy: regulating medicines in the UK, it states:-

"All voluntary reporting systems suffer from underreporting. The proportion of suspected adverse drug reactions which are reported is very variable, and it has been estimated that only around 10-25 per cent of reactions experienced by patients are reported."

It continues:

"The Agency considers that the level of reporting by some groups, for example hospital doctors, is particularly low. Our survey highlighted some of the reasons doctors do not participate.

The most common reasons given by GPs and hospital doctors for not reporting adverse effects of medicines

• recently tried to report online but found I couldn't so didn't bother

• uncertain of the threshold for serious reactions

• not my responsibility to report

• not really sure what should be reported

• too busy

• it takes a long time to fill out the form

• it is not easy to find Yellow Card when necessary

• reporting generates too much extra work

• too junior to fill in a card

• the system is not convenient

• it never comes to mind at the right time"

• On 31st October 2003, the Medicine Control Agency Press Release promised that 'Drug Side Effect Reporting Scheme Moves Into the 21st Century'.

http://www.mca.gov.uk/whatsnew/pressreleases/yellowcard_311002.pdf

It also said:-

"We would like to encourage nurses to help us test and evaluate the usefulness of the electronic Yellow Card by using this method when reporting suspected ADRs.

Paul Burstow MP has proposed a 3-point plan to reduce the underreporting of Adverse Drug Reactions:-

• Pilot and evaluate a scheme to allow patients to be given the right to report suspected ADRs to a hotline. While not being the Yellow Card Scheme, it could work alongside it and compliment reports from professionals

• Pilot and evaluate a scheme to allow Black Triangle drugs to be marked as such and an explanation should run by the side of it so that patients know that it is a new and still being tested as a new drug.

• Consultations with the relevant professional and patient bodies on how to improve yellow card reporting, including the reporting of suspected ADRs. In particular this should focus on whether reporting should remain on a voluntary basis as it is now or put on a statutory basis

Inappropriate Medication

Mr. Burstow: To ask the Secretary of State for Health, pursuant to his answer of 10 July 2002, Official Report, column 1037W, on inappropriate medication, how many people died from (a) suffering adverse reactions and (b) being prescribed inappropriate medication in each (i) health authority and (ii) region in each of the last five years. [71946]

Mr. Lammy [holding answer 22 July 2002]: Reports of suspected adverse drug reactions (ADRs) to medicines are collected by the Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the yellow card scheme. There are approximately 20,000 reports of ADRs reported to the MCA and CSM through the yellow card scheme each year, of which approximately 3 per cent. report a fatal suspected ADR.

There are four regional monitoring centres (RMCs) that act locally on behalf of the CSM to collect reports of ADRs and to stimulate ADR reporting through local initiatives. These are CSM Mersey, CSM Wales, CSM Northern and CSM West Midlands. The table shows the total number of suspected ADR reports and reports with a fatal outcome received via the Yellow Card Scheme from 1997 to 2001. It includes the number of suspected ADR reports and reports with a fatal outcome received in each of the RMCs. A breakdown of ADR data by health authority is not available. Data from the yellow card scheme cannot be used to measure the frequency of an ADR in a particular region or health authority as ADR reporting is associated with an unknown and a variable degree of under reporting.

It is important to note that submission of a suspected ADR report does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease.

Separate figures are not available on adverse reactions resulting from patients being prescribed inappropriate medication.

Total number of Adverse Drug Reaction (ADR) Reports and Reports with a Fatal Outcome from 1997 to 2001Received by the Medicines Control Agency (MCA) from the Adverse Drug ReactionsOn-line Information Tracking (ADROIT) Database

Year 1997 1998 1999 2000 2001

Total No. of ADR Reports: 16,628 18,057 18,488 33,129 21,358

Total No. of Reports with a Fatal Outcome: 455 529 560 610 608

Percentage: 3% 3% 3% 2% 3%